Novelos Therapeutics Discontinues Current Development Program for NOV-002 in NSCLC

NEWTON, Mass.--(BUSINESS WIRE)--Mar 18, 2010 -
Novelos Therapeutics, Inc. (OTCBB:
NVLT), a biopharmaceutical company focused on the development
of therapeutics to treat cancer and hepatitis, today announced that
primary and secondary endpoints were not met in Novelos' pivotal
Phase 3 trial in advanced non-small cell lung cancer (NSCLC) with
its lead product, NOV-002, in combination
with first-line chemotherapy. Adding NOV-002 to paclitaxel and
carboplatin chemotherapy was not statistically or meaningfully
different in terms of efficacy-related endpoints or recovery from
chemotherapy toxicity versus chemotherapy alone. NOV-002 was safe,
as it did not add to the overall toxicity of chemotherapy. Detailed
trial results are expected to be presented at the 2010 annual
meeting of the American Society of Clinical Oncology (ASCO) taking
place June 4-8 in Chicago, Illinois.

This randomized, controlled, open-label Phase 3 trial, conducted
under a Special Protocol Assessment (SPA) and Fast Track
designation, enrolled 903 patients with Stage IIIb/IV NSCLC and
included all histological subtypes. The trial encompassed
approximately 100 clinical sites in 12 countries and evaluated
NOV-002 in combination with first-line paclitaxel and carboplatin
chemotherapy versus paclitaxel and carboplatin alone. The primary
efficacy endpoint of the trial was improvement in overall survival.
Secondary endpoints included progression free survival, response
rate and duration of response, recovery from chemotherapy-induced
myelosuppression, determination of immunomodulation, quality of
life and safety. Based on results from this Phase 3 trial, Novelos
will discontinue development of NOV-002 for NSCLC in combination
with first-line paclitaxel and carboplatin chemotherapy.

“We designed and executed a robust Phase 3 NSCLC trial,
but disappointingly, NOV-002 did not work in this very difficult to
treat indication in combination with this chemotherapy,” said
Harry Palmin, President and CEO of Novelos. “Moving forward,
our Phase 2 programs continue in cancer and hepatitis with our
oxidized glutathione-based compounds. We expect results from an
ongoing NOV-002 Phase 2 breast cancer trial in 3Q 2010, and are
scheduled to present new NOV-002 nonclinical data at the American
Association for Cancer Research (AACR) Annual Meeting in April
2010. We also expect to initiate a Phase 2 hepatitis C trial
shortly with our second compound NOV-205. Meanwhile, we intend to
rebuild our pipeline through licensing or acquiring clinical-stage
oncology compounds, utilizing our experienced and proven
development team.”

About Novelos Therapeutics, Inc.

Novelos Therapeutics, Inc. is a biopharmaceutical company
commercializing oxidized glutathione-based compounds for the
treatment of cancer and hepatitis. Novelos is seeking to build a
pipeline through licensing or acquiring clinical stage compounds or
technologies for oncology indications. Our lead compound, NOV-002,
has been administered to approximately 1,000 cancer patients in
clinical trials and is in Phase 2 development for solid tumors in
combination with chemotherapy. Novelos has a partnership with
Mundipharma, an independent associated company of Purdue Pharma, to
develop and commercialize NOV-002 in Europe and Asia (excluding
China). Novelos' second compound, NOV-205, which has been
administered to approximately 200 hepatitis patients in clinical
trials, is in Phase 2 development for chronic hepatitis C
non-responders. Both compounds have been partnered with Lee's Pharm
in China. For additional information about Novelos please visit
www.novelos.com.

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subject to known and unknown risks and uncertainties that may cause
actual future experience and results to differ materially from the
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compounds, the successful preclinical development thereof, the
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